AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE:7754) will hold a pre-IPO briefing at 2 pm on Jul 20 at Grand Hyatt Taipei, with First Securities Inc. serving as the lead underwriter. The company is scheduled to list on the Emerging Stock Board on July 25 at the reference price of NTD$45 per share.

AnnJi, founded in NTU Innovation and Incubation Center, is a new drug company dedicated to developing first-in-class and best-in-class innovative small molecules (NCEs). The company is committed to addressing significant unmet medical needs in the therapeutic areas of neurology, dermatology, and rare diseases.

AnnJi stands out for its great potential as one of the few companies in Taiwan with its innovative drug pipeline that spans from translational research and preclinical studies to clinical development. AnnJi has received multiple prestigious honors, including the international Boehringer Ingelheim-Grass Roots Innovation Award, as well as national accolades such as the 19th National Innovation Award and the 2023 Outstanding Company Award.

AnnJi is led by a highly capable management team with comprehensive expertise in translational research and product development, focusing on neglected diseases with significant unmet medical needs, including neurodegenerative disorders, dermatological conditions and rare diseases.

AJ201

AJ201 is a novel small molecule therapy under development for Spinal and Bulbar Muscular Atrophy (SBMA), also known as Kennedy’s disease, a rare neuromuscular disorder. AnnJi has signed an exclusive licensing agreement with Avenue Therapeutics Inc., a U.S.-based NASDAQ-listed biopharmaceutical company, covering the U.S. and European markets. The total deal value amounts to up to USD 250 million.

AJ201 is the first first-in-class small molecule to enter clinical trials in SBMA patients in two decades. The Phase 1b/2a clinical trial in the United States has been completed, with topline results expected by mid-year.

AJ302

AJ302 is a novel, highly selective HDAC6 inhibitor developed independently by AnnJi for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Globally, approximately 68% of cancer patients undergoing chemotherapy experience neurotoxic side effects, and around 30% develop chronic neuropathic pain associated with CIPN.

AJ302 is designed to target the root causes of CIPN by enhancing the acetylation of microtubule proteins within nerve bundles, a critical process in neuronal repair and regeneration. This mechanism positions AJ302 as a first-in-class therapeutic candidate for CIPN. The compound has already received FDA clearance to initiate clinical trials, and a Phase I study is scheduled to begin this year.

The global CIPN treatment market is projected to grow from USD 1.54 billion in 2023 to USD 2.25 billion by 2028, at a compound annual growth rate (CAGR) of 8%, driven by the increasing prevalence of cancer, widespread use of chemotherapy, and the lack of effective, approved treatment options. With its unique mechanism and strong preclinical data, AJ302 is well-positioned to address this urgent unmet medical need and capture a significant share of this expanding market.

Amid accelerating challenges from population aging and environmental pollution, the prevalence of chronic dermatological and neurological conditions continues to rise. To address these pressing unmet medical needs, AnnJi has developed a strategic pipeline focused on targeted therapeutic areas.

Under the leadership of Dr. Wendy Huang, a veteran with over 40 years of global pharmaceutical experience, AnnJi’s lead candidate AJ201 has progressed into Phase II clinical trials in the US with AJ302 sets to enter clinical development. These efforts lay a strong foundation for future licensing opportunities and market entry.

AnnJi is backed by a robust group of major investors, including Taiwania Capital, TaiAn Technologies, Mega Bank, Taiwan Cooperative Bank, Chang Hwa Bank, Taiwan Business Bank, GAINS Investment, and Industrial Technology Investment Corporation (ITIC) – representing key government and government-owned venture capital institutions. The company has gained the trust and support of leading professional biotech and financial investors such as Fubon Financial, PIDC, SinoPac Holdings, Orient EuroPharma etc.

AnnJi plans to submit its IPO application within the next two years and is widely regarded as one of the most promising emerging stars in Taiwan’s capital market.

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Kennedy’s disease, also known as Spinal and Bulbar Muscular Atrophy (SBMA), is a rare and serious inherited neuromuscular degenerative disorder. It is characterized by the progressive degeneration of lower motor neurons in the spinal cord, brainstem, and skeletal muscles. The disease primarily affects males between the ages of 30 and 40, with an estimated prevalence of 1 in 300,000. As the disease progresses—typically by age 50—patients often develop difficulties with chewing and swallowing, and ultimately, recurrent aspiration pneumonia becomes a common cause of death. Currently, there are no approved treatments for SBMA.

CIPN is one of the most common neurological complications experienced by cancer patients during and after chemotherapy. Symptoms typically include tingling, numbness, and burning sensations, which can severely impact a patient’s quality of life and ability to perform daily activities such as walking, dressing, or writing.

CIPN can also compromise the effectiveness of cancer treatment. For example, among breast cancer patients receiving paclitaxel (a commonly used chemotherapeutic agent), up to 80% report CIPN symptoms, and 50% of those patients require dose adjustments or modifications to their treatment plan.

Currently, there are no approved therapies specifically for CIPN. As a result, patients often resort to reducing chemotherapy doses or relying on antidepressants for symptomatic relief, despite their limited efficacy in managing neuropathic pain.